Contact Point Reduction Garment

ABSTRACT

The present disclosure provides a wearable garment comprising (a) a sheath having a first end and a second, wherein the sheath defines a cavity in a wearable position, wherein the sheath has a first opening at the first end, and wherein the sheath comprises a first material, and (b) one or more relief zones coupled to the sheath, wherein the relief zones comprise a second material, wherein a pressure distribution of the second material is greater than a pressure distribution of the first material.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/251,544 filed Aug. 30, 2016, which claims priority to (i)U.S. Provisional Application No. 62/212,250 entitled “Contact PointReduction Garment,” filed on Aug. 31, 2015, and (ii) U.S. ProvisionalApplication No. 62/308,410 entitled “Contact Point Reduction Garment,”filed on Mar. 15, 2016, the contents of each of which are herebyincorporated by reference in their entirety.

BACKGROUND THE INVENTION

Wounds may be defined as damage to the skin and underlying tissues. Suchwounds often happen in patients with diabetes or circulatory impairment.The circulatory impairment can manifest as lymphedema, venousinsufficiency, or elevated pressure which can compromise localizedmicrovasculature, as examples. Lymphedema and venous insufficiency are aresult of fluid not being returned to the heart properly. Localizedelevated pressure, which results in pressure ulcers, can result fromflow being stopped through the microvasculature, where nutrients areexchanged between the blood and tissue.

Venous ulcers often accompany varicose veins and most often affect thedistal leg and ankle. They are usually painful, large in size, andexudative. Venous ulcers may become recurrent at times and can havevarying depths. They occur from blood pooling in the ankle which createsa chronic tension on the delicate skin of the ankle. Such woundstypically occur on the sides of the ankle. Recommended ways forpreventing venous ulcers include elevating the extremity and alsoapplying graduated compressive stockings. Elevating the extremityrequires applying a force to the underside of the heel. Unfortunatelythis can create areas of localized pressure on the heel. To preventthis, heel pillows have been developed. Compressive stockings can alsocreate a risk of creating a pressure ulcer over any of the bonyprominences of the foot should the localized pressure created exceed thecapillary pressure and thus create localized regions of ischemia.

Pressure ulcers can occur anywhere following prolonged periods ofsustained pressure. Such pressure ulcers can become life/limbthreatening. In elderly patients, the skin on the distal extremity canbe extremely fragile and thin. Further, the foot and ankle has severalbony prominences which may create areas of increased pressures when thefoot is wrapped or when the patient lies in bed for a prolonged periodof time. When a patient is confined to bed rest after a medicalprocedure, tissue necrosis may occur due to various externally appliedforces to the lower extremities of the patient. For example, simplepressure from the patient's foot resting on a mattress can lead totissue necrosis in the bony areas of the foot. In order to preventpressure ulcers, heel pillows (noted above) and gel filled bandages havebeen developed. Heel pillows distribute forces thereby effectivelyreducing localized pressure but are associated with certaindisadvantages. For example, heel pillows are not intended for use duringthe act of walking and only protect the heel region. Because of thedifficulty of walking with a heel pillow, patient compliance with heelpillows is typically very poor. The gel in bandages offloads force frombony prominences and also helps to reduce shear stress and friction onthe skin that often lead to wound formation. Hospitals also developprotocols for periodically turning patients to prevent prolongedlocalized regions of pressure and ultimately pressure ulcers that mayresult.

SUMMARY OF THE INVENTION

Wounds of the local extremities can often be multifactorial with botharterial and venous contributing factors. The inventor recognized thatcompression may be needed but is ill-advised if there is some arterialcompromise or tissue fragility. Accordingly, the invention describedherein provides an apparatus that may be used to distribute forces overthese areas to effectively reduce regions of high pressure and preventpressure ulcers. For example, the disclosed garment is configured to beworn on a distal extremity to encourage the distribution of forces andreduction of pressure over the bony prominences of the body.

More specifically, as mentioned above, if local applied pressure exceedsthe capillary pressure of a patient due to confined bed rest orcompressive bandages, for example, localized ischemia may result andtissue necrosis may follow. To address this, a contact point reductiongarment is provided herein to address tissue necrosis in theextremities. In one example, the contact point reduction garment is awearable garment that may include one or more relief zones positionedover the bony areas of the foot to help to move some of the pressure ofthe bandage away from the bony area and transfer it to the softer tissueareas of the foot. Thus, the invention may take the form of acompression sock or hose that has padding built into these relief zones,thereby reducing the occurrence of tissue necrosis in bedridden orambulatory individuals. In another example, the wearable garmentdescribed herein may be used in the region of the knee and may preventexcess pressure around the hamstring tendon or gracilis muscle, forexample. In yet another example, the wearable garment described hereinmay be used in the region of the elbow and may prevent excess pressurearound the elbow.

Thus, in one aspect, the present disclosure provides a wearable garmentcomprising (a) a sheath having a first end and a second, wherein thesheath defines a cavity in a wearable position, wherein the sheath has afirst opening at the first end, and wherein the sheath comprises a firstmaterial, and (b) one or more relief zones coupled to the sheath,wherein the relief zones comprise a second material, wherein a pressuredistribution of the second material is greater than a pressuredistribution of the first material.

These as well as other aspects, advantages, and alternatives, willbecome apparent to those of ordinary skill in the art by reading thefollowing detailed description, with reference where appropriate to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a medial perspective view of a wearable garment, according toan example embodiment.

FIG. 2 is a lateral perspective view of the wearable garment, accordingto the example embodiment of FIG. 1 .

FIG. 3 a posterior view of the wearable garment, according to theexample embodiment of FIG. 1 .

FIG. 4 is an anterior view of the wearable garment, according to theexample embodiment of FIG. 1 .

FIG. 5 is a medial side view of a wearable garment, according to anexample embodiment.

FIG. 6 is a lateral side view of the wearable garment, according to theexample embodiment of FIG. 5 .

FIG. 7 is a lateral side view and bottom view of a wearable garment,according to an example embodiment.

FIG. 8 is a lateral side view of the wearable garment, according to theexample embodiment of FIG. 7 .

FIG. 9 is a lateral side view and medial side view of the wearablegarment, according to the example embodiment of FIG. 7 .

FIG. 10 is a bottom view of the wearable garment, according to theexample embodiment of FIG. 7 .

FIG. 11 is a medial perspective view of a wearable garment, according toan example embodiment.

FIG. 12 is a top view of the wearable garment, according to the exampleembodiment of FIG. 11 .

DETAILED DESCRIPTION OF THE INVENTION

Exemplary devices and methods are described herein. It should beunderstood that the word “exemplary” is used herein to mean “serving asan example, instance, or illustration.” Any embodiment or featuredescribed herein as “exemplary” is not necessarily to be construed aspreferred or advantageous over other embodiments or features. Theexemplary embodiments described herein are not meant to be limiting. Itwill be readily understood that certain aspects of the disclosed systemsand methods can be arranged and combined in a wide variety of differentconfigurations, all of which are contemplated herein.

Furthermore, the particular arrangements shown in the Figures should notbe viewed as limiting. It should be understood that other embodimentsmay include more or less of each element shown in a given Figure.Further, some of the illustrated elements may be combined or omitted.Yet further, an exemplary embodiment may include elements that are notillustrated in the Figures.

As used herein, with respect to measurements, “about” means +/−5%.

As used herein, “pressure distribution” means a maximum pressure valueexperienced in response to any non-physiological force applied to alower extremity of a user.

As used herein, “bilateral” means of, at, toward, or from the side orsides of the human body.

As used herein, “medial” means situated in the middle or near the medianplane of the body.

As used herein, “distal” means situated away from the center of the bodyor from the point of attachment.

As used herein, “posterior” means further back in position, of or nearthe rear or hind end of the body or a part of it.

As used herein, “proximal” means situated nearer to the center of thebody or the point of attachment.

As used herein, “anterior” means nearer the front, especially situatedin the front of the body or nearer the head.

As used herein, “cuneiform” means bones that are in the mid-foot andattached to the navicular bone on the proximal extent and themetatarsals on the distal extent. The cuneiforms are attachment pointsfor several ligaments and are involved in articulation of the joints ofthe foot.

As used herein, “metatarsal bones” means bones that are connected to theproximal phalanges on the distal end and the cuneiform bones and cuboidbone on the proximal end. The metatarsal bones are divided into threeparts: the base, body, and head. The head is closest to the toes.

As used herein, “scaphoid (navicular) tubercle” means a bony prominencethat extends from the medial portion of the foot where the tibialisposterior muscle attaches. The navicular bone articulates proximallywith the talas, distally with the three cuneiform bones, and laterallywith the cuboid.

As used herein, “malleolus” means a bony projection on each side of thehuman ankle.

As used herein, “medial malleolus” means the prominence on the innerside of the ankle formed by the lower end of the tibia.

As used herein, “lateral malleolus” means the prominence on the outerside of the ankle, formed by the lower end of the fibula.

As used herein, “relief zone” means a portion of the garment that isintended to distribute compressive forces on the foot effectivelyreducing pressure.

As used herein, “first end” means the proximal end of the garment, awayfrom the toes of the feet.

As used herein, “second end” means the distal end of the garment or theend in close proximity to the toes of the feet.

As used herein, “ischemia” means an inadequate blood supply to an organor part of the body, in this case the tissue of the foot around a bonyprominence.

As used herein, “capillary pressure” means a pressure in the blood nearthe capillary, which is reduced substantially, to approximately 2 kPa,from blood pressure allowing the transfer of nutrients and wasteproducts.

As used herein, “inferior glue” means a glue that creates a nonpermanentreusable mechanical connection between two surfaces.

With reference to the Figures, FIGS. 1-6 illustrate a wearable garment100 according to an example embodiment. In particular, as shown in FIGS.1-6 , the wearable garment 100 may include a sheath 102 having a firstend 104 and a second end 106. The sheath includes a first material anddefines a cavity 110 in a wearable position, and the sheath 102 has afirst opening 112 at the first end 104. The first material may comprisea breathable matrix, a cotton material, Polytetrafluoroethylene (PTFE),polyester, an elastic material, or combinations thereof, among otherpossibilities. The first material may include an elastic property suchthat the sheath 102 is configured to expand to receive an appendage of auser, and thereafter retract to conform to the appendage of the user tothereby hold the wearable garment 100 in place on the appendage.

The wearable garment 100 also includes one or more relief zones 114coupled to the sheath 102. The relief zones 114 include a secondmaterial. A pressure distribution of the second material of the reliefzones 114 is greater than a pressure distribution of the first materialof the sheath 102. As such, the second material of the relief zones 114includes one or more pad structures, as shown labeled 114 in FIG. 4 ,shaped to be positioned adjacent one or more surfaces of a lowerextremity. The sheath 102 and relief zones 114 are configured such thata peak localized pressure imparted by the first material in response toan externally applied force is greater than a peak localized pressureimparted by the second material in response to the externally appliedforce applied to the extremities of the wearer. Such an externallyapplied force may simply be from the pressure from the patient's footresting on a mattress.

The second material may include a polyurethane foam, an encapsulatedgel, an encapsulated liquid, a polymer, an encapsulated plasma, anencapsulated gas, or combinations thereof, among other possibilities.The second material may be encapsulated by an encapsulating materialthat is deformable, biocompatible and capable of compatibility with thegel, liquid, plasma, and/or gas. In such an example, a volume of thesecond material may be variable via injection or extraction of a gel, aliquid, a plasma or a gas into or out of the encapsulating material.Further, the encapsulating material may be self-sealing such that theencapsulating material may be externally accessed by an instrument(e.g., punctured by a needle) and then remain sealed upon removal of theinstrument (e.g., needle). In addition, the wearable garment 100 mayfurther include a one-way valve or a two-way valve coupled to the one ormore relief zones 114 to permit an instrument to access the secondmaterial and thereby adjust a volume of the second material viainjection or extraction. Other example arrangements are possible aswell.

In various embodiments, the first and second materials, respectively,may comprise a breathable matrix and a polyurethane foam, a breathablematrix and an encapsulated gel, a breathable matrix and an encapsulatedliquid, a breathable matrix and a polymer, a breathable matrix and anencapsulated plasma, a breathable matrix and an encapsulated gas, acotton material and a polyurethane foam, a cotton material and anencapsulated gel, a cotton material and an encapsulated liquid, a cottonmaterial and a polymer, a cotton material and an encapsulated plasma, acotton material and an encapsulated gas, Polytetrafluoroethylene(“PTFE”)vand a polyurethane foam, PTFE and an encapsulated gel, PTFE andan encapsulated liquid, PTFE and a polymer, PTFE and an encapsulatedplasma, PTFE and an encapsulated gas, polyester and a polyurethane foam,polyester and an encapsulated gel, polyester and an encapsulated liquid,polyester and a polymer, polyester and an encapsulated plasma, polyesterand an encapsulated gas, an elastic material and a polyurethane foam, anelastic material and an encapsulated gel, an elastic material and anencapsulated liquid, an elastic material and a polymer, an elasticmaterial and an encapsulated plasma, or an elastic material and anencapsulated gas, among other possibilities.

As discussed above, the first material of the sheath 102 is differentfrom the second material of the one or more relief zones 114 such that apressure distribution of the second material is greater than a pressuredistribution of the first material. The respective pressuredistributions of the first and second materials may be controlled by thematerial properties, respective thicknesses of those materials or volume(in the case of an encapsulated second material) and/or thread count.The pressure distribution properties of a given material may be definedby a maximum localized pressure value experienced in response to a forceapplied to the given material. A peak localized pressure of the firstmaterial in response to an externally applied force is greater than apeak localized pressure of the second material in response to theexternally applied force. Thus, the second material may distribute theapplied force on the tissue of the user so as to reduce the peaklocalized pressure in response to the externally applied force to beless than a mean capillary perfusion pressure. In addition, the firstmaterial's peak localized pressure helps to maintain the wearablegarment 100 in place on the respective body part on which the wearablegarment 100 was disposed.

In one example, the wearable garment 100 further includes at least onesecond opening 116 in the second end 106 of the sheath 102. The at leastone second opening 116 may include five openings each configured toreceive a toe of a user. In another example, the at least one secondopening 116 may be a single opening. In one example, the single openingmay be configured to receive five toes of a user or to accommodate anappendage disposed through the cavity of the sheath, such as an arm or aleg. In yet another example, shown in FIGS. 1-6, and 11 , the at leastone second opening 116 is a single opening arranged adjacent to a medialside of the wearable garment 100 and configured to receive a hallux toeof a user. In yet another embodiment, the second end 106 of the sheath102 is closed such that the sheath 102 is configured to cover the toesof a user, as shown in FIGS. 7-10 .

The one or more relief zones 114 may take a variety of forms. In oneexample, the one or more relief zones 114 comprise at least one of afirst distal metatarsal head zone 118, a fifth proximal and distalmetatarsal head zone 120, a cuneiform zone 122, an anterior shin zone124, an Achilles zone 126, a medial malleolus zone 128, a heel zone 130,a scaphoid tubercle zone 132, and a lateral malleolus zone 134. Thefirst material may be positioned adjacent the surfaces of the lowerextremity extending between and connecting the various relief zones 114,as shown in FIGS. 1-6 . Though the edges of the second material mayoverlap with the first material for coupling. The second material is ata size and thickness necessary to adequately distribute the appliedexternal force on the tissue of the user so as to reduce the localizedpressure to be less than the mean capillary perfusion pressure, therebyreducing the risk of tissue necrosis. Further, the interior surface 136of the sheath 102 may include an adhesive material to prevent thewearable garment 100 from slipping down the anterior shin of the user,for example. Such an adhesive material may include silicone, or anymaterial with a moderate bio-adhesive nature, particularly a materialthat does not need to be wet to exhibit the bio-adhesive properties.

In another example, the first end 104 of the sheath 102 is configured tolie above a knee joint of a user, and the second end 106 of the sheath102 is configured to lie below the knee joint of the user. In such anexample, the one or more relief zones 114 comprise at least one of ananterior side, a posterior side, a medial side or a lateral side of athigh region, a posterior side, a medial side or a lateral side of acalf region, a shin region, a knee cap region or a popliteal fossaregion. In yet another example, the first end 104 of the sheath 102 isconfigured to lie above an elbow joint of a user, and the second end 106of the sheath 102 is configured to lie below the elbow joint of theuser. In such an example, the one or more relief zones 114 include atleast one of a triceps zone, a biceps zone, a bursa zone, an ulna zone,a radius zone, and an olecranon zone.

In one example, the second material is coupled to an interior surface136 of the first material. In another example, the second material maybe layered between additional materials in the one or more relief zones114. For example, the one or more relief zones 114 may be arranged suchthat the second material is disposed between two layers of the firstmaterial. In another example, the one or more relief zones 114 mayinclude a layer of the first material having an inner surface coupled toa layer of the second material, where an inner surface of the secondmaterial is coupled to a layer of a bio-adhesive material arranged tointerface with a user's appendage. In yet another example, the one ormore relief zones 114 may include a layer of the first material havingan inner surface coupled to a layer of the second material arranged tointerface with the user's appendage. Other examples are possible aswell.

In one example, the one or more relief zones 114 may be removablycoupled to the interior surface 136 of the first material. In anotherexample, the one or more relief zones 114 may be removably coupled to anexterior surface 138 of the first material. In such examples, the one ormore relief zones 114 may include a plurality of hooks configured toremovably couple with a plurality of loops on the first material. Inanother example, the one or more relief zones 114 may be removablycoupled to the first material using one or more magnets, zippers,mechanical fasteners, buttons, an inferior glue, or any othernonpermanent reusable mechanical connection. Such embodiments may enablea medical professional to move the one or more relief zones 114 based onthe particular patient. Further, such one or more relief zones 114 maybe customizable such that the one or more relief zones 114 comprisingthe second material may be cut to allow for user specific customization.Such an embodiment may enable a medical professional to specificallytailor the size, shape, and/or thickness of the one or more relief zones114 based on the particular patient.

In the example shown in FIGS. 1-6 , the sheath 102 may include a footregion 140, a heel region 142, and a shin region 144. In such anexample, the foot region 140 and the shin region 144 are coupledtogether via the heel region 142 such that the foot region 140 and theshin region 144 are arranged substantially perpendicular to one another.The outer perimeter of the plantar side 146 of the foot region 140 mayhave an oval shape, an elliptical shape or a plantar shape. The one ormore relief zones 114 are coupled to at least one of a dorsal side 146,a medial side 148 or a lateral side 150 of the foot region 140, aposterior side 152, a medial side 154 or a lateral side 156 of the heelregion 142, a posterior side 158, a medial side 160 or a lateral side162 of the shin region 144 such that the one or more relief zones 114are not arranged on a plantar side 164 of the foot region 140. In oneparticular example, as shown in FIGS. 7-10 , the one or more reliefzones 114 comprises a first relief zone 166 coupled to the medial side148 of the foot region 140 of the sheath 102, a second relief zone 168coupled to the lateral side 150 of the foot region 140 of the sheath102, a third relief zone 170 coupled to the heel region 142 of thesheath 102, and a fourth relief zone 172 coupled to a shin region 144 ofthe sheath 102.

Further, the foot region 140 may be coupled to the heel region 142 via afirst seam, and the shin region 144 may be coupled to the heel region142 via a second seam. In such an example, the first seam and the secondseam may be positioned on an outer surface 138 of the wearable garment100 such that the seams do not contact the tissue of the user. Such aconfiguration may help prevent abrasion sores created by the seams beingon the inside of the wearable garment 100.

The pressure distributing nature of the second material may reduce theuser's ability to detect tactile sensations on the plantar surface ofthe foot. If this is the case, the user may have trouble walking and maybe at risk for a fall. For this reason, in one example embodiment, theplantar surface 164 of the foot region 140 may include only the firstmaterial and/or a third material (described in more detail below), butnot the second material.

FIGS. 7-10 illustrate such an embodiment. As shown in FIGS. 7-10 , theone or more relief zones 114 of the wearable garment 100 are coupled toat least one of a dorsal side 146, a medial side 148 or a lateral side150 of the foot region 140, a posterior side 152, a medial side 154 or alateral side 156 of the heel region 142, a posterior side 158, a medialside 160 or a lateral side 162 of the shin region 144 such that the oneor more relief zones 114 are not arranged on a plantar side 164 of thefoot region 140. As such, as shown in FIGS. 7-10 , the one or morerelief zones 114 may be absent from a bottom surface or plantar surface164 of the sheath 102. Such an embodiment may beneficially increase theability of a user to sense a surface upon which he/she walks. In such anexample, the bottom surface or plantar surface 164 of the sheath 102 mayinclude a third material to provide a gripping interface to frictionallyengage the surface on which the user is walking. As such, the thirdmaterial may be on an outer surface of the sheath 102. In such anexample, the third material has a higher coefficient of friction thanthe first material. In one example, the third material may comprise anon-skid material such as silicone, neoprene, fluoroelastomer,fluorosilicone, or plastisol inks, although other non-skid materials arepossible as well. The third material may be patterned or coat the entiresurface of the plantar surface 164 of the sheath 102. In one particularexample, as shown in FIGS. 7 and 10, the bottom surface of the sheathmay include a plurality of silicone protrusions to provide the grippinginterface. Other arrangements of the third material are possible aswell. Further, as shown in FIGS. 7-10 , the second end 106 of the sheath102 of the wearable garment 100 may be closed, thereby concealing auser's toes. In such an example, the sheath 102 is configured to coverthe toes of a user like a sock.

FIGS. 11-12 illustrate yet another embodiment of the wearable garment100. As shown in FIGS. 11-12 , the wearable garment may include aseparable seam 174 extending from the first end 104 to the second end106. In the example shown in FIG. 11 , the separable seam 174 is on theanterior side of the wearable garment 100. The separable seam 174 mayenable the wearable garment 100 to transition from a closed state wherethe wearable garment 100 forms a tubular structure to an open statewhere the wearable garment 100 forms a semi-tubular or semi-flatstructure with optional preformed contours to receive such areas likethe heel, medial/lateral malleolus, and medial/lateral metatarsal heads.As such, a medical professional may separate the separable seam 174 totransition the wearable garment 100 to the open state to place thewearable garment 100 on a patient, and then close the separable seam 174once the wearable garment 100 is positioned on the patient to transitionthe wearable garment 100 to the closed state, thereby securing thewearable garment 100 to the patient. In such an example, as shown inFIG. 12 , the one or more relief zones 114 may include at least a reliefzone on an anterior side of the wearable garment 100, positionedposterior to the separable seam 174. In such an example, the relief zone114 is positioned under the separable seam 174, closest to the skin ofthe patient. This arrangement ensures that the separable seam 174 doesnot contact the tissue of the user. Such a configuration may helpprevent abrasion sores that would otherwise be created by the separableseam 174 being arranged on the inside of the wearable garment 100.

As shown in FIG. 12 , a first portion 176 of the wearable garment 100overlaps with a second portion 178 of the wearable garment 100 to formthe separable seam 174. As shown in FIG. 12 , the first portion 176 maybe on an anterior side of the wearable garment 100, while the secondportion 178 is posterior to the first portion 176. The first portion 176may be separably coupled to the second portion 178 in a variety of ways,including one of a hook and fastener system, a mechanical fastener, azipper, a string, one or more straps, one or more magnets, an inferiorglue, or any other nonpermanent reusable mechanical connection. Further,the wearable garment 100 may include one or more shape-memory rings 180positioned at one or more of the first end 104, the second end 106, or amiddle section 182 of the wearable garment 100. The shape-memory ring180 may include nitinol, as an example, although other materials arepossible as well. Such a shape-memory ring 180 may cause the wearablegarment 100 to bias to the closed position.

One example method for limiting development of tissue necrosis in asubject in need thereof includes determining, from a plurality of sizedwearable garments of any one of the foregoing embodiments, anappropriately sized wearable garment to fit a foot of the subject,positioning the wearable garment on the foot of the subject, andmaintaining the wearable garment on the foot of the subject for a periodof time and under conditions effective to limit development of tissuenecrosis. In one example, there may be a plurality of sized wearablegarments, such as a small, medium, large, and extra-large size dependingon the patient. In another example, the sheath 102 may be customizablesuch that the sheath 102 may be cut to allow for user specificcustomization.

In another embodiment, the method may further comprise securing thewearable garment to the subject via one or more of an elastic band andstretchable stitching surrounding the at least one opening at the secondend of the wearable garment. In such an example, the wearable garmentmay include one or more of an elastic band 113, straps, and stretchablestitching at the first end of the sheath surrounding the first openingthat is configured to receive a user's foot and ankle therethrough. Asanother example, the wearable garment may include one or more of anelastic band, straps, and stretchable stitching surrounding the at leastone second opening at the second end of the wearable garment to receiveone or more toes of a user. Such configurations would enable the user toadjust the fit of the wearable garment to ensure the wearable garmentstays secure to the lower extremity.

It will be appreciated that other arrangements are possible as well,including some arrangements that involve more or fewer steps than thosedescribed above, or steps in a different order than those describedabove.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.All embodiments within and between different aspects of the inventioncan be combined unless the context clearly dictates otherwise. Thevarious aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the claims.

1. A pressure reduction garment comprising: a sheath having a first endand a second end, wherein the sheath defines a cavity in a wearableposition configured to receive an appendage of a user, wherein thesheath has a first opening at the first end, and wherein the sheathcomprises a first material; and one or more relief zones coupled to thesheath, wherein the one or more relief zones comprise a second materialdifferent from the first material, wherein the second material comprisesa gel, wherein a pressure distribution of the second material is greaterthan a pressure distribution of the first material, wherein the one ormore relief zones comprise a first relief zone configured to cover afirst metatarsal head of the user, a second relief zone configured tocover a fifth metatarsal head of the user, a third relief zoneconfigured to cover a medial malleolus, a lateral malleolus, a heel, andan Achilles of the user, and a fourth relief zone configured to cover acuneiform and a shin of the user, wherein the first material surroundseach of the first relief zone, the second relief zone, the third reliefzone, and the fourth relief zone such that each relief zone is separatedfrom each of the other relief zones by the first material, and whereinan interior surface of the sheath includes an adhesive materialconfigured to contact the shin of the user to prevent the pressurereduction garment from slipping down the shin of the user.
 2. Thepressure reduction garment of claim 1, wherein a volume of the secondmaterial is variable via injection or extraction into or out of anencapsulating material that encapsulates the second material.
 3. Thepressure reduction garment of claim 2, wherein the encapsulatingmaterial is self-sealing.
 4. The pressure reduction garment of claim 2,further comprising a valve coupled to the one or more relief zones. 5.The pressure reduction garment of claim 1, wherein the sheath comprisesa first layer and a second layer, the first layer comprising the firstmaterial, wherein the second layer of the sheath is configured tocontact the appendage of the user when in use, and wherein the secondmaterial of the one or more relief zones is arranged between the firstlayer and the second layer of the sheath.
 6. The pressure reductiongarment of claim 5, wherein an inner surface of the second material iscoupled to a layer of a bio-adhesive material arranged to contact theappendage of the user when in use.
 7. The pressure reduction garment ofclaim 1, wherein a layer of the first material of the sheath includes aninner surface coupled to a layer of the second material arranged tocontact the appendage of the user when in use.
 8. The pressure reductiongarment of claim 1, wherein the second material is configured to reducea peak localized pressure from a weight of the appendage resting on asurface to be less than a mean capillary perfusion pressure.
 9. Thepressure reduction garment of claim 1, wherein the second end of thesheath has at least one second opening.
 10. The pressure reductiongarment of claim 9, wherein the at least one second opening comprisesfive openings each configured to receive a toe of a user.
 11. Thepressure reduction garment of claim 9, wherein the at least one secondopening is a single opening.
 12. The pressure reduction garment of claim9, further comprising one or more of an elastic band and stretchablestitching surrounding the at least one second opening at the second endof the sheath.
 13. The pressure reduction garment of claim 1, furthercomprising one or more of an elastic band and stretchable stitchingsurrounding the first opening.
 14. The pressure reduction garment ofclaim 1, wherein the second end of the sheath is closed such that thesheath is configured to cover the toes of a user.
 15. The pressurereduction garment of claim 1, wherein the first material comprises abreathable matrix, a cotton material, Polytetrafluoroethylene (PTFE),polyester, an elastic material, or combinations thereof.
 16. Thepressure reduction garment of claim 1, wherein the one or more reliefzones are coupled to an interior surface of the first material.
 17. Thepressure reduction garment of claim 1, wherein the wearable positionfurther comprises a calf region and a foot region, wherein the calfregion and the foot region are substantially perpendicular to oneanother.
 18. The pressure reduction garment of claim 17, wherein abottom surface of the foot region of the sheath comprises a thirdmaterial having a higher coefficient of friction than the firstmaterial.
 19. The pressure reduction garment of claim 18, wherein thethird material comprises silicone, neoprene, fluoroelastomer,fluorosilicone or plastisol inks.
 20. The pressure reduction garment ofclaim 1, wherein the first material has an elastic property such thatthe sheath is configured to expand to receive the appendage of the user,and thereafter retract to conform to the appendage to thereby hold thepressure reduction garment in place on the appendage.
 21. The pressurereduction garment of claim 1, wherein the one or more relief zones areremovably coupled to an exterior surface of the first material.
 22. Thepressure reduction garment of claim 1, wherein the one or more reliefzones are removably coupled to an interior surface of the firstmaterial.
 23. The pressure reduction garment of claim 22, wherein theone or more relief zones include a plurality of hooks configured toremovably couple with a plurality of loops on the first material. 24.The pressure reduction garment claim 1, further comprising: a separableseam extending from the first end to the second end.
 25. The pressurereduction garment of claim 24, wherein the one or more relief zonescomprise at least an anterior side of the pressure reduction garment,positioned posterior to the separable seam.
 26. The pressure reductiongarment of claim 24, wherein the separable seam comprises one of a hookand fastener system, a mechanical fastener, a zipper, a string, one ormore straps, one or more magnets, or an interior glue.